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Monday, November 17, 2008

No one expects Sidney Wolfe to sit on his hands at an FDA advisory committee meeting, and at his first outing as a permanent member of the Drug Safety & Risk Management Advisory Committee, he didn’t disappoint.

During a two-day meeting last week to consider the approvability of two abuse-resistant pain medications, Wolfe took a few minutes to grouse about one of his favorite topics, direct-to-consumer advertising, and specifically Purdue’s $600 million fine over misleading advertising and promotion of OxyContin. Here’s what he said:

“The gorilla, or donkey or elephant in the room is advertising and promotion. If OxyContin was that dangerous ... maybe it would be off the market. The number-one culprit—and the number two, three, four, five, six and seven—and the reason for the $650 million penalty was misleading advertising and promotion.”

Wolfe also couldn’t help but take a dig at the two products up for approval decisions: Alpharma’s abuse-resistant form of morphine, Embeda, and Pain Therapeutics’ abuse-resistant form of oxycontin, Remoxy. (Neither drug won kudos from advisory committee members; you can read our coverage on those meetings here and here).

“Any company that wants to develop...a product that is novel and has significant benefits over existing products—something I haven’t seen over the last couple of days—is going to spend a huge amount of money advertising and promoting,” Wolfe said.

It’s true that advisory committee members sometimes go off the reservation on issues like pricing and insurance coverage. And we don’t necessarily disagree with what Wolfe is saying—we’ve also suggested that industry take a hard look at DTC advertising and whether it’s really worth all the potential political and legal headaches.

But for companies with products slated to go before Drug Safety & Risk Management Advisory Committee—and given the ubiquitous nature of REMS, there will be many—those are the type of comments to expect out of Wolfe. In the case of Embeda and Remoxy, his comments only reinforced the direction the committee was headed in anyway. That may not be the case next time.

What’s next for Wolfe? The next meeting of the Drug Safety & Risk Management Advisory Committee is two-day discussion on the safety of long-acting beta agonist inhalers in December. That’s big-name products like GSK’s Advair, AstraZeneca’s Symbicort and Schering-Plough’s Foradil. Stay tuned.

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